Every material Form 8-K Invivyd, Inc. has filed with the SEC since August 13, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Invivyd reported topline results from the Phase 3 LIBERTY study of its investigational COVID-19 antibody VYD2311, which it says showed a safety and tolerability profile superior to an mRNA COVID-19 vaccine. The company also plans to submit a Biologics License Application to the FDA under the Accelerated Approval pathway, pending data from the ongoing DECLARATION pivotal study expected in October 2026. For shareholders, the results come from a 210-person study, and the regulatory path depends on DECLARATION data that have not yet been reported.
VYD2311 alone: 56.5% of subjects had a treatment-emergent adverse event, injection site reaction or hypersensitivity reaction over 6 days, versus 91.4% in the mRNA vaccine arm (P<0.0001).
VYD2311 combined with the mRNA vaccine: 78.9% versus 91.4% on the same measure, with P=0.057 for that comparison.
DECLARATION topline safety and immunogenicity data are expected in October 2026; that study enrolls approximately 2,400 participants.
LIBERTY enrolled 210 healthy adults aged 18 to 49, randomized 1:1:1 across three arms.
Invivyd, Inc. appointed Chairman Marc Elia as Chief Executive Officer effective August 30, 2026, taking over as principal executive officer from William Duke, Jr., who remains Chief Financial Officer. The company also added Ian Sheffield to its board and named Ajay Royan Lead Independent Director, and the company said VYD2311 top-line data is still expected around the end of Q3 2026.
Marc Elia, Chairman since July 2022, became CEO effective August 30, 2026, and will also remain Chairman.
Elia's employment agreement provides a $750,000 base salary, a 70% target bonus, a $500,000 sign-on bonus, and an option to buy 10,700,000 shares.
Ian Sheffield was appointed a director on August 30, 2026, and Ajay Royan was named Lead Independent Director.
Invivyd expects top-line data from the VYD2311 program around the end of Q3 2026.
Invivyd reported second-quarter 2026 PEMGARDA net product revenue of $14.3 million, up 21% from $11.8 million a year earlier. Net loss grew to $44.4 million, or $0.14 per share, from $14.7 million, or $0.12 per share, as R&D and SG&A expenses rose sharply for the VYD2311 clinical trials and commercial activities, which matters to shareholders because the company's cash of $160.1 million is expected to fund operations through the DECLARATION pivotal data readout.
Q2 2026 R&D expenses were $29.4 million, up from $9.6 million, mainly from DECLARATION and LIBERTY trial costs.
Q2 2026 SG&A expenses were $29.5 million, up from $16.6 million.
Cash and cash equivalents were $160.1 million as of June 30, 2026.
In July 2026, Invivyd received twelve months' advance notice of the termination of the PEMGARDA emergency use authorization.
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